To investigate the pH of the acid in the stomach of healthy volunteers after the intakeof Gaviscon Double Action liquid.
Conditions
Interventions
Trade Name: Gaviscon Dual 500 Mg / 213 Mg /325 Mg Suspension Zum einnehmen im Beutel
Product Name: Gaviscon Double Action Liquid Sachets
Pharmaceutical Form: Oral suspe
Sponsors
Reckitt Benckiser Healthcare (UK) Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only subjects to whom all of the following conditions apply will be included: 1. Male or female subjects who have given written informed consent. 2. Age: = 18 years = 50 years. 3. Body Mass Index (BMI): = 18.5 and = 24.9 kg/m2. 4. Height = 1.90 metres 5. Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -A history of gastro-oesophageal reflux or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year. -Clinically significant diseases of the body system. -A medical history that is associated with an increased risk in study procedures (e.g. basal skull fracture or those who have undergone trans-sphenoidal surgery). -Hospitalisation within the previous three months for major surgery or medical illness. -A clinically significant illness within the 4 weeks prior to screening. -Ingestion of any prescription medication or non-prescription medication within the seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study. -Ingestion of antacids, H2 antagonists, motility stimulants (e.g. prokinetics, macrolide antibiotics such as erythromycin and azithromycin, and 5-hydroxytryptamine [5HT] agonists such as sumatriptan) or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to enrolment in the study and during the study and/or have taken proton pump inhibitors in the 4 weeks prior to enrolment into the study and during the study. Enrolment is defined as the date of informed consent signature. -Those who are currently taking any of the following medications: antihistamines, tetracyclines, digoxin, quinolones including fluoroquinolone, iron salts, neuroleptics, thyroxine and levothyroxine, penicillamine, beta-blockers (e.g. atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, biphosphonates, ketoconazole, eltrombopag and Thiazide diuretics. -A history of drug hypersensitivity, which in the opinion of the Principal Investigator might interfere with the study. -A history of allergy or intolerance to either IMP or the following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), glucose syrup, carbomer, xanthan gum. -A current or recent history (within one year of the screening visit) of alcohol abuse or significant abuse/misuse of any legal or illegal drugs, substances and solvents. -Those with a positive screen/test for drugs of abuse and/or alcohol. -Those who regularly (weekly) consume excessive amounts of alcohol (> 8 units for men and > 6 units for women in one consumption, excessive amounts as defined by the UK National Office of Statistics). -Those who have consumed more than 2 units of alcohol per day in the 7 days prior to the screening visit and from the screening visit up to 48 hours before admission to the Clinical Unit for Treatment Period 1. -Those who have consumed alcohol within the 48 hours before admission to the Clinical Unit for Treatment Period 1 and there is insufficient time for the visit to be rescheduled. -Those who regularly consume excessive quantities of caffeine (> 6 cups of tea, coffee or cola per day), according to the Investigator’s judgement. -Those who have consumed caffeine-containing food and drinks within the 48 hours before admission to the Clinical Unit for Treatment Period 1 and there is insufficient time for the visit to be rescheduled. -Those who are either unable to refrain from using tobacco/nicotine during the study trea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective of this study is to assess the safety of the test formulation.;Primary end point(s): The primary endpoint will be the mean percentage of time that pH = 4 over 0-30 minutes post-dose across electrodes 5 to 10. The primary analysis will be the comparison of this endpoint between Gaviscon Double Action Liquid and placebo liquid, within ;Timepoint(s) of evaluation of this end point: Over a minimum of 30 minutes post-dose;Main Objective: The primary objective of this confirmatory study is to confirm the acid neutralisation action of Gaviscon Double Action Liquid versus placebo liquid, within the stomach. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • The mean percentage of time that pH = 4 over the interval 30-60 minutes post-dose across electrodes 5 to 10. • The mean percentage of time that pH = 3 over the intervals 0-30 minutes and 30-60 minutes post-dose across electrodes 5 to 10. • The mean percentage of time that pH = 3 and pH = 4 over the 10 minute intervals post-dose across electrodes 5 to 10. • The percentage of time that pH = 3 and pH = 4 over the 10 minute and 30 minute intervals at each electrode. These endpoints will be compared between Gaviscon Double Action Liquid and placebo. The following will be displayed non-comparatively: • The pH value measured every 4 seconds during each monitoring period at each electrode. Safety endpoints: • The occurrence of Adverse Events • The absolute value and change from baseline in each vital sign, ECG parameter and physical examination • The absolute value and change from baseline in each haematology, biochemistry and urinary test ;Timepoint(s) of evaluation of this end point: As detailed in E.5.2 | — |
Countries
Netherlands
Contacts
Public ContactVictoria Hodgkinson
Reckitt Benckiser Healthcare (UK) Limited
Outcome results
None listed